US6858199B1 - High efficient delivery of a large therapeutic mass aerosol - Google Patents
High efficient delivery of a large therapeutic mass aerosol Download PDFInfo
- Publication number
- US6858199B1 US6858199B1 US09/591,307 US59130700A US6858199B1 US 6858199 B1 US6858199 B1 US 6858199B1 US 59130700 A US59130700 A US 59130700A US 6858199 B1 US6858199 B1 US 6858199B1
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- Prior art keywords
- particles
- bioactive agent
- receptacle
- powder
- subject
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
- A61K31/198—Alpha-aminoacids, e.g. alanine, edetic acids [EDTA]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
Abstract
Description
d aer =d g√ρtap
where dg is the geometric diameter, for example the MMGD and ρ is the powder density. Experimentally, aerodynamic diameter can be determined by employing a gravitational settling method, whereby the time for an ensemble of particles to settle a certain distance is used to infer directly the aerodynamic diameter of the particles. An indirect method for measuring the mass median aerodynamic diameter (MMAD) is the multi-stage liquid impinger (MSLI).
- (1) RODOS dry powder disperser (Sympatec Inc., Princeton, N.J.)
- (2) HELOS laser diffractometer (Sympatec Inc., N.J.)
- (3) Single-stage Andersen impactor (Andersen Inst., Sunyma, Ga.)
- (4) AeroDisperser (TSI, Inc., Amherst, Mass.)
- (5) Aerosizer (TSI Inc., Amherst, Mass.)
- (6) blister pack machine, Fantasy Blister Machine (Schaefer Tech, Inc., Indianapolis, Ind.)
- (7) collapsed Andersen cascade impactor (consisting of
stage 0 as defined by manufacturer) and the filter stage (Anderson Inst., Sunyra, Ga.) - (8) a spirometer (Spirometrics, USA, Auburn, Me.)
- (9) a multistage liquid impinger (MSLI) (Erweka, USA, Milford, Conn.)
- (10) fluorescent spectroscope (Hitachi Instruments, San Jose, Calif.)
- (11) gamma camera (generic)
Reagents - albuterol sulfate particles (Profarrnco Inc., Italy)
- human growth hormone (Eli Lilly, Indianapolis, Ind.)
-
size # 2 methyl cellulose capsules (Shionogi, Japan) - blister packs (Heuck Foils, Well, N.J.)
- DPPC (Avanti, Alabaster, Ala.)
TABLE 1 | ||||
Powder | Dg (μm) | ρ(g/cc) | ||
Micronized Alb. Sulfate (1) | 2.5 | 0.26 | ||
Spray-Dried Alb. Sulfate (2) | 8.0 | 0.20 | ||
Spray-Dried hGH (3) | 14.5 | 0.07 | ||
Claims (49)
Priority Applications (29)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/591,307 US6858199B1 (en) | 2000-06-09 | 2000-06-09 | High efficient delivery of a large therapeutic mass aerosol |
DK01942072T DK1296663T3 (en) | 2000-06-09 | 2001-06-08 | Very effective delivery of an aerosol with great therapeutic mass |
US09/878,146 US7556798B2 (en) | 2000-06-09 | 2001-06-08 | Highly efficient delivery of a large therapeutic mass aerosol |
DE60127407T DE60127407T2 (en) | 2000-06-09 | 2001-06-08 | HIGH-ACTIVE ADMINISTRATION OF AEROSOL WITH HIGH THERAPEUTIC MASS |
KR1020027016748A KR100697479B1 (en) | 2000-06-09 | 2001-06-08 | Highly efficient delivery of a large therapeutic mass aerosol |
PT01942072T PT1296663E (en) | 2000-06-09 | 2001-06-08 | Highly efficient delivery of a large therapeutic mass aerosol |
MXPA02012023A MXPA02012023A (en) | 2000-06-09 | 2001-06-08 | Highly efficient delivery of a large therapeutic mass aerosol. |
NZ523254A NZ523254A (en) | 2000-06-09 | 2001-06-08 | Method of delivering a large therapeutic mass aerosol to the pulmonary system |
JP2002510053A JP2004503482A (en) | 2000-06-09 | 2001-06-08 | Highly efficient delivery of large therapeutic mass aerosols |
CN01812533A CN100589796C (en) | 2000-06-09 | 2001-06-08 | Highly efficient delivery of large therapeutic mass aerosol |
SI200130734T SI1296663T1 (en) | 2000-06-09 | 2001-06-08 | Highly efficient delivery of a large therapeutic mass aerosol |
IL15328101A IL153281A0 (en) | 2000-06-09 | 2001-06-08 | Highly efficient delivery of a large therapeutic mass aerosol |
CA002412561A CA2412561C (en) | 2000-06-09 | 2001-06-08 | Highly efficient delivery of a large therapeutic mass aerosol |
PCT/US2001/018491 WO2001095874A2 (en) | 2000-06-09 | 2001-06-08 | Highly efficient delivery of a large therapeutic mass aerosol |
AU2001275368A AU2001275368B2 (en) | 2000-06-09 | 2001-06-08 | Highly efficient delivery of a large therapeutic mass aerosol |
EP07000049A EP1767196A3 (en) | 2000-06-09 | 2001-06-08 | Highly efficient delivery of a large therapeutic mass aerosol |
AT01942072T ATE357222T1 (en) | 2000-06-09 | 2001-06-08 | HIGHLY EFFECTIVE ADMINISTRATION OF A HIGH THERAPEUTIC MASS AEROSOL |
PL36028701A PL360287A1 (en) | 2000-06-09 | 2001-06-08 | Highly efficient delivery of a large therapeutic mass aerosol |
ES01942072T ES2283417T3 (en) | 2000-06-09 | 2001-06-08 | HIGH EFFECTIVENESS DISTRIBUTION OF A HIGH AMOUNT OF THERAPEUTIC AEROSOL |
AU7536801A AU7536801A (en) | 2000-06-09 | 2001-06-08 | Highly efficient delivery of a large therapeutic mass aerosol |
EP01942072A EP1296663B1 (en) | 2000-06-09 | 2001-06-08 | Highly efficient delivery of a large therapeutic mass aerosol |
RU2002134467/15A RU2275900C2 (en) | 2000-06-09 | 2001-06-08 | Method for delivering aerosol of large therapeutic mass in highly effective mode |
NO20025873A NO20025873L (en) | 2000-06-09 | 2002-12-06 | Very effective delivery of a large therapeutic amount of aerosol |
HK03103294A HK1051139A1 (en) | 2000-06-09 | 2003-05-12 | Highly efficient delivery of a large therapeutic mass aerosol |
US10/681,416 US6921528B2 (en) | 2000-06-09 | 2003-10-08 | Highly efficient delivery of a large therapeutic mass aerosol |
JP2008222436A JP2009019047A (en) | 2000-06-09 | 2008-08-29 | Highly efficient delivery of large therapeutic mass aerosol |
US12/253,449 US20090068274A1 (en) | 2000-06-09 | 2008-10-17 | Highly efficient delivery of a large therapeutic mass aerosol |
US13/334,236 US8628754B2 (en) | 2000-06-09 | 2011-12-22 | Highly efficient delivery of a large therapeutic mass aerosol |
US14/101,500 US20140178476A1 (en) | 1999-06-22 | 2013-12-10 | Highly Efficient Delivery of a Large Therapeutic Mass Aerosol |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/591,307 US6858199B1 (en) | 2000-06-09 | 2000-06-09 | High efficient delivery of a large therapeutic mass aerosol |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US33724599A Continuation-In-Part | 1999-06-22 | 1999-06-22 |
Related Child Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/878,146 Continuation-In-Part US7556798B2 (en) | 1999-06-22 | 2001-06-08 | Highly efficient delivery of a large therapeutic mass aerosol |
US10/681,416 Division US6921528B2 (en) | 2000-06-09 | 2003-10-08 | Highly efficient delivery of a large therapeutic mass aerosol |
Publications (1)
Publication Number | Publication Date |
---|---|
US6858199B1 true US6858199B1 (en) | 2005-02-22 |
Family
ID=24365965
Family Applications (6)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/591,307 Expired - Lifetime US6858199B1 (en) | 1999-06-22 | 2000-06-09 | High efficient delivery of a large therapeutic mass aerosol |
US09/878,146 Active 2025-02-09 US7556798B2 (en) | 1999-06-22 | 2001-06-08 | Highly efficient delivery of a large therapeutic mass aerosol |
US10/681,416 Expired - Lifetime US6921528B2 (en) | 2000-06-09 | 2003-10-08 | Highly efficient delivery of a large therapeutic mass aerosol |
US12/253,449 Abandoned US20090068274A1 (en) | 1999-06-22 | 2008-10-17 | Highly efficient delivery of a large therapeutic mass aerosol |
US13/334,236 Expired - Fee Related US8628754B2 (en) | 1999-06-22 | 2011-12-22 | Highly efficient delivery of a large therapeutic mass aerosol |
US14/101,500 Abandoned US20140178476A1 (en) | 1999-06-22 | 2013-12-10 | Highly Efficient Delivery of a Large Therapeutic Mass Aerosol |
Family Applications After (5)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/878,146 Active 2025-02-09 US7556798B2 (en) | 1999-06-22 | 2001-06-08 | Highly efficient delivery of a large therapeutic mass aerosol |
US10/681,416 Expired - Lifetime US6921528B2 (en) | 2000-06-09 | 2003-10-08 | Highly efficient delivery of a large therapeutic mass aerosol |
US12/253,449 Abandoned US20090068274A1 (en) | 1999-06-22 | 2008-10-17 | Highly efficient delivery of a large therapeutic mass aerosol |
US13/334,236 Expired - Fee Related US8628754B2 (en) | 1999-06-22 | 2011-12-22 | Highly efficient delivery of a large therapeutic mass aerosol |
US14/101,500 Abandoned US20140178476A1 (en) | 1999-06-22 | 2013-12-10 | Highly Efficient Delivery of a Large Therapeutic Mass Aerosol |
Country Status (21)
Country | Link |
---|---|
US (6) | US6858199B1 (en) |
EP (2) | EP1767196A3 (en) |
JP (2) | JP2004503482A (en) |
KR (1) | KR100697479B1 (en) |
CN (1) | CN100589796C (en) |
AT (1) | ATE357222T1 (en) |
AU (2) | AU7536801A (en) |
CA (1) | CA2412561C (en) |
DE (1) | DE60127407T2 (en) |
DK (1) | DK1296663T3 (en) |
ES (1) | ES2283417T3 (en) |
HK (1) | HK1051139A1 (en) |
IL (1) | IL153281A0 (en) |
MX (1) | MXPA02012023A (en) |
NO (1) | NO20025873L (en) |
NZ (1) | NZ523254A (en) |
PL (1) | PL360287A1 (en) |
PT (1) | PT1296663E (en) |
RU (1) | RU2275900C2 (en) |
SI (1) | SI1296663T1 (en) |
WO (1) | WO2001095874A2 (en) |
Cited By (52)
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US20030235536A1 (en) * | 2002-03-15 | 2003-12-25 | The Brigham And Women's Hospital, Inc. | Central airway administration for systemic delivery of therapeutics |
US20040071781A1 (en) * | 2002-10-11 | 2004-04-15 | Ferro Corporation | Composite particles and method for preparing |
US20040105820A1 (en) * | 1997-09-29 | 2004-06-03 | Weers Jeffry G. | Phospholipid-based powders for inhalation |
WO2004112702A2 (en) | 2003-06-13 | 2004-12-29 | Advanced Inhalation Research, Inc. | Low dose pharmaceutical powders for inhalation |
US20050191360A1 (en) * | 2004-02-10 | 2005-09-01 | Advanced Inhalation Research, Inc. | Particles for inhalation having rapid release properties |
US20060171899A1 (en) * | 1998-12-10 | 2006-08-03 | Akwete Adjei | Water-stabilized aerosol formulation system and method of making |
US20070123449A1 (en) * | 2005-11-01 | 2007-05-31 | Advanced Inhalation Research, Inc. | High load particles for inhalation having rapid release properties |
US20070151560A1 (en) * | 2003-06-12 | 2007-07-05 | Robert Price | Delivery device for a powder aerosol |
US20070253913A1 (en) * | 2003-09-10 | 2007-11-01 | Nahed Mohsen | Aerosol formulations for delivery of dihydroergotamine to the systemic circulation via pulmonary inhalation |
US20080241253A1 (en) * | 1999-08-25 | 2008-10-02 | Advanced Inhalation Research, Inc. | Formulations for Spray-Drying Large Porous Particles |
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